RODEO-MaPS: The RODEO Micro Mapping Catheter in Cryoablation Procedures

Sponsor

afreeze GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04845750

Collaborator

Competence Center for Medical Devices GmbH (Other)

Enrollment

Locations

Arm

21.6

Anticipated Duration (Months)

18.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).

Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases	Device: Rodeo Micro Mapping Catheter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rodeo Micro Mapping Catheter Determination of pulmonary vein isoation during cryoablation procedure	Device: Rodeo Micro Mapping Catheter The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation

Arm

Intervention/Treatment

Experimental: Rodeo Micro Mapping Catheter

Determination of pulmonary vein isoation during cryoablation procedure

Device: Rodeo Micro Mapping Catheter

The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation

Outcome Measures

Primary Outcome Measures

Feasibility of the Rodeo Micro Mapping Catheter [1-3 hours]
Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.
Positioning of the Rodeo Micro Mapping Catheter [1-3 hours]
Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible

Secondary Outcome Measures

Safety of the Rodeo Micro Mapping Catheter. [1-3 day follow-up period]
Percentage of adverse events related to the Rodeo Micro Mapping Catheter
Efficacy of the Rodeo Micro Mapping Catheter [1-3 hours]
Percentage of successfully isolated pulmonary veins
Real-time pulmonary vein isolation [1-3 hours]
Time from beginning of the freeze to conduction blockade (time to effect)
Procedural safety [1-3 hours]
Procedure-related adverse events
Total procedure time [1-3 hours]
Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath
Cryoablation catheter procedure time [1-3 hours]
Cryoablation catheter procedure time defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application
Total fluoroscopy time and dose [1-3 hours]
Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath
Cryoablation catheter fluoroscopy time and dose [1-3 hours]
Cryoablation catheter fluoroscopy time and dose defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years and legal capacity.
Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version

- permanent AF excluded.

Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).

Exclusion Criteria:

Indication that the vascular system is not accessible through the left or right groin.
Indication that a transseptal puncture cannot be performed.
Any previous ablation or surgery due to AF.
Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
Left atrial diameter > 50 mm in the short axis.
Advanced structural heart disease including
moderate-to-severe valvular stenosis or regurgitation,
previous valve replacement or valve repair,
congenital heart disease,
left ventricular ejection fraction < 45% during sinus rhythm,
congestive heart failure NYHA III or IV,
coronary artery bypass graft surgery within the last 3 months.
Permanent pacemaker.
Pregnant women at the time of the cryoablation procedure.
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
Participation in interventional trials for cardiovascular devices or drugs.